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Sample Size Calculations for SMARTs

Publication ,  Journal Article
Rose, EJ; Laber, EB; Davidian, M; Tsiatis, AA; Zhao, Y-Q; Kosorok, MR
June 16, 2019

Sequential Multiple Assignment Randomized Trials (SMARTs) are considered the gold standard for estimation and evaluation of treatment regimes. SMARTs are typically sized to ensure sufficient power for a simple comparison, e.g., the comparison of two fixed treatment sequences. Estimation of an optimal treatment regime is conducted as part of a secondary and hypothesis-generating analysis with formal evaluation of the estimated optimal regime deferred to a follow-up trial. However, running a follow-up trial to evaluate an estimated optimal treatment regime is costly and time-consuming; furthermore, the estimated optimal regime that is to be evaluated in such a follow-up trial may be far from optimal if the original trial was underpowered for estimation of an optimal regime. We derive sample size procedures for a SMART that ensure: (i) sufficient power for comparing the optimal treatment regime with standard of care; and (ii) the estimated optimal regime is within a given tolerance of the true optimal regime with high-probability. We establish asymptotic validity of the proposed procedures and demonstrate their finite sample performance in a series of simulation experiments.

Duke Scholars

Publication Date

June 16, 2019
 

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Rose, E. J., Laber, E. B., Davidian, M., Tsiatis, A. A., Zhao, Y.-Q., & Kosorok, M. R. (2019). Sample Size Calculations for SMARTs.
Rose, Eric J., Eric B. Laber, Marie Davidian, Anastasios A. Tsiatis, Ying-Qi Zhao, and Michael R. Kosorok. “Sample Size Calculations for SMARTs,” June 16, 2019.
Rose EJ, Laber EB, Davidian M, Tsiatis AA, Zhao Y-Q, Kosorok MR. Sample Size Calculations for SMARTs. 2019 Jun 16;
Rose, Eric J., et al. Sample Size Calculations for SMARTs. June 2019.
Rose EJ, Laber EB, Davidian M, Tsiatis AA, Zhao Y-Q, Kosorok MR. Sample Size Calculations for SMARTs. 2019 Jun 16;

Publication Date

June 16, 2019